FDA Grants Moderna COVID Vaccine Full Approval After Slight Delay

The Food and Drug Administration has finally given full approval to the COVID-19 vaccine distributed by Moderna.

The agency announced on Monday that they had completed their extensive review of Moderna's vaccine against the coronavirus. The FDA also announced that it will now be marketed using the name Spikevax. Results were supposedly expected to be released earlier, but more review was said to be needed on the data.

"The FDA's approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19. The public can be assured that Spikevax meets the FDA's high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States," said Acting FDA Commissioner Dr. Janet Woodcock in a statement. "​​While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated."

In order to reach the decision, months of post-dosage data recorded by Moderna was reviewed. Furthermore, the FDA studied any potential side effects that could be detrimental to users. Only one was warned of in the official ruling, which was mild and rare heart inflammation that normally occurs in young men.

Although their entire testing process is undisclosed to the public, the FDA's top vaccine regulator Dr. Peter Marks assured that the decision to approve Spikevax was one that was steeped in medical and scientific data.

"Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants," said Dr. Marks in the FDA statement. "The public can be assured that this vaccine was approved in keeping with the FDA's rigorous scientific standards."

Moderna in Japan
The U.S.' Food and Drug Administration fully approved of Moderna's COVID-19 vaccine on Monday. Above, vials of the Moderna COVID-19 vaccine are being prepared for local residents in a tray at a mass vaccination center operated by Japanese Self-Defense Force in Tokyo on January 31, 2022. Photo by Eugene Hoshiko/Pool/AFP via Getty Images

Meanwhile, Moderna is celebrating the approval and praising the FDA for its decision.

"Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death," said Moderna's Chief Executive Officer Stéphane Bancel. "The totality of real-world data and the full BLA for Spikevax in the United States reaffirms the importance of vaccination against this virus. This is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the U.S. The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved. We are grateful to the U.S. FDA for their thorough review of our application. We are humbled by the role that Spikevax is playing to help end this pandemic."

Around 63 percent of the total American population is fully vaccinated against COVID-19, the equivalent of more than 211 million people. Over 200 million doses of the Moderna vaccine have been distributed since December 2020.

Moderna in Italy
The U.S.' Food and Drug Administration announced that they have fully approved of Moderna's COVID-19 vaccine on Monday. Above, empty Moderna vaccine flasks on January 23, 2022, in Bari, Italy. Photo by Donato Fasano/Getty Images